scholarly journals Continuous monitoring of health data with a wearable device in pediatric patients undergoing chemotherapy for cancer – a feasibility pilot study

Author(s):  
Brack Eva ◽  
Koenig Christa ◽  
Roessler Jochen ◽  
Ammann Roland A.

Abstract Pediatric patients with cancer are at high risk for severe infections and delayed treatment increases mortality. Infections can trigger changes of vital signs long before clinical symptoms arise. Continuous recording may detect such changes earlier than discrete measurements. This is the protocol for an investigator-initiated, single-center observational pilot study on the feasibility of continuous monitoring of health data with a wearable device (WD) in pediatric patients undergoing chemotherapy of cancer. A total of 20 patients will be included, including at least 4 patients <6 years. Each patient will wear the WD for 14 days and we expect study duration of three to four months. The protocol had been registered at www.clinicaltrials.com (NCT04134429) and was approved by the local Ethics Committees (Ethikkommission der Universitätskinderkliniken Bern, “Gesuch 1912”, Kantonale Ethikkommission Bern, BASEC-No.: 2019-01919).

Author(s):  
Christa Koenig ◽  
Roland A. Ammann ◽  
Claudia E. Kuehni ◽  
Jochen Roessler ◽  
Eva Brack

Abstract Purpose Pediatric patients with cancer are at high risk for severe infections. Infections can trigger changes of vital signs long before clinical symptoms arise. Continuous recording may detect such changes earlier than discrete measurements. We aimed to assess the feasibility of continuous recording of vital signs by a wearable device (WD) in pediatric patients undergoing chemotherapy for cancer. Methods In this prospective, observational single-center study, pediatric patients under chemotherapy wore the Everion® WD for 14 days. The predefined patient-specific goal was heart rate recorded in good quality during ≥18/24 h per day, on ≥7 consecutive days. The predefined criterion to claim feasibility was ≥15/20 patients fulfilling this patient-specific goal. Results Twenty patients were included (median age, 6 years; range, 2–16). Six patients aged 3–16 years fulfilled the patient-specific goal. Quality of heart rate recording was good during 3992 of 6576 (61%) hours studied and poor during 300 (5%) hours, and no data was recorded during 2284 (35%) hours. Eighteen of 20 participants indicated that this WD is acceptable to measure vital signs in children under chemotherapy. Conclusion The predefined feasibility criterion was not fulfilled. This was mainly due to important compliance problems and independent of the WD itself. However, continuous recording of vital signs was possible across a very wide age range in pediatric patients undergoing chemotherapy for cancer. We recommend to study feasibility in the Everion® again, plus in further WDs, applying measures to enhance compliance. Trial registration ClinicalTrials.gov (NCT04134429) on October 22, 2019.


2021 ◽  
Author(s):  
Christa Koenig ◽  
Roland A Ammann ◽  
Claudia E Kuehni ◽  
Jochen Roessler ◽  
Eva Brack

Abstract PurposePediatric patients with cancer are at high risk for severe infections. Infections can trigger changes of vital signs long before clinical symptoms arise. Continuous recording may detect such changes earlier than discrete measurements. We aimed to assess the feasibility of continuous recording of vital sings by a wearable device (WD) in pediatric patients undergoing chemotherapy for cancer.MethodsIn this prospective, observational single-center study pediatric patients undergoing chemotherapy for cancer wore the Everion® WD for 14 days.ResultsTwenty patients were included (median age, 6 years; range, 2-16). Six patients (predefined feasibility criterion, ≥15 patients) aged 3-16 years fulfilled the patient specific goal, defined as heart rate recorded with good quality during ≥18 hours/day on ≥7 consecutive days. The quality of heart rate recording was good during 3992 of 6576 (61%) hours studied, poor during 300 (5%) hours, and no data was recorded during 2284 (35%) hours. Eighteen of 20 participants indicated that this WD is acceptable to measure vital sings in children undergoing chemotherapy for cancer. ConclusionWe found that continuous recording of vital signs is feasible across a very wide age range in pediatric patients undergoing chemotherapy for cancer. In the configuration studied, however, the predefined feasibility criterion was not fulfilled. This was mainly due to important compliance problems and independent of the WD itself. These results will influence the design of future WD-studies including those aiming to identify patterns predicting fever or infection. This study was registered at ClinicalTrials.gov (NCT04134429) the 22th of October, 2019.


2021 ◽  
Author(s):  
Mariska Weenk ◽  
Harry van Goor ◽  
Bas Frietman ◽  
Lucien JLPG Engelen ◽  
Cornelis JHM van Laarhoven ◽  
...  

UNSTRUCTURED REMOVE


2018 ◽  
Author(s):  
Candice Downey ◽  
Rebecca Randell ◽  
Julia Brown ◽  
David G Jayne

BACKGROUND Vital signs monitoring is a universal tool for the detection of postoperative complications; however, unwell patients can be missed between traditional observation rounds. New remote monitoring technologies promise to convey the benefits of continuous monitoring to patients in general wards. OBJECTIVE The aim of this pilot study was to evaluate whether continuous remote vital signs monitoring is a practical and acceptable way of monitoring surgical patients and to optimize the delivery of a definitive trial. METHODS We performed a prospective, cluster-randomized, parallel-group, unblinded, controlled pilot study. Patients admitted to 2 surgical wards at a large tertiary hospital received either continuous and intermittent vital signs monitoring or intermittent monitoring alone using an early warning score system. Continuous monitoring was provided by a wireless patch, worn on the patient’s chest, with data transmitted wirelessly every 2 minutes to a central monitoring station or a mobile device carried by the patient’s nurse. The primary outcome measure was time to administration of antibiotics in sepsis. The secondary outcome measures included the length of hospital stay, 30-day readmission rate, mortality, and patient acceptability. RESULTS Overall, 226 patients were randomized between January and June 2017. Of 226 patients, 140 were randomized to continuous remote monitoring and 86 to intermittent monitoring alone. On average, patients receiving continuous monitoring were administered antibiotics faster after evidence of sepsis (626 minutes, n=22, 95% CI 431.7-820.3 minutes vs 1012.8 minutes, n=12, 95% CI 425.0-1600.6 minutes), had a shorter average length of hospital stay (13.3 days, 95% CI 11.3-15.3 days vs 14.6 days, 95% CI 11.5-17.7 days), and were less likely to require readmission within 30 days of discharge (11.4%, 95% CI 6.16-16.7 vs 20.9%, 95% CI 12.3-29.5). Wide CIs suggest these differences are not statistically significant. Patients found the monitoring device to be acceptable in terms of comfort and perceived an enhanced sense of safety, despite 24% discontinuing the intervention early. CONCLUSIONS Remote continuous vital signs monitoring on surgical wards is practical and acceptable to patients. Large, well-controlled studies in high-risk populations are required to determine whether the observed trends translate into a significant benefit for continuous over intermittent monitoring. CLINICALTRIAL International Standard Randomised Controlled Trial Number ISRCTN60999823; http://www.isrctn.com /ISRCTN60999823 (Archived by WebCite at http://www.webcitation.org/73ikP6OQz)


2017 ◽  
Vol 5 (7) ◽  
pp. e91 ◽  
Author(s):  
Mariska Weenk ◽  
Harry van Goor ◽  
Bas Frietman ◽  
Lucien JLPG Engelen ◽  
Cornelis JHM van Laarhoven ◽  
...  

10.2196/31899 ◽  
2021 ◽  
Vol 9 (7) ◽  
pp. e31899
Author(s):  
Mariska Weenk ◽  
Harry van Goor ◽  
Bas Frietman ◽  
Lucien JLPG Engelen ◽  
Cornelis JHM van Laarhoven ◽  
...  


Author(s):  
Hisako Hara ◽  
Makoto Mihara ◽  
Takeshi Todokoro

Lymphedema is a chronic edema that sometimes occurs after treatment of gynecologic cancer, and cellulitis often occurs concomitantly with lymphedema. On the other hand, necrotizing fasciitis (NF) is a relatively rare, but life-threatening disease. The symptoms in cellulitis and NF are very similar. In this case report, we describe a case in which the diagnosis of NF in a lymphedematous limb was difficult. A 70-year-old woman had secondary lymphedema in bilateral legs and consulted our department. On the first day of lymphedema therapy, the patient complained of vomiting, diarrhea, and fever (37.7 °C) without local fever in the legs. She was diagnosed with acute gastroenteritis. On the next day, swelling and pain in her left leg occurred and her blood pressure was 59/44 mmHg. She was diagnosed with cellulitis accompanied by lower limb lymphedema and septic shock. On the second day, blisters appeared on the left leg, and computed tomography showed NF. We performed debridement under general anesthesia and her vital signs improved postoperatively. Streptococcus agalactiae (B) was detected in blood culture, and we administered bixillin and clindamycin. Postoperatively, necrosis in the skin and fat around the left ankle gradually spread, and it took 5 months to complete epithelialization. The diagnosis was more difficult than usual NF because patients with lymphedema often experience cellulitis. Clinicians should always think of NF to avoid mortality due to delayed treatment. This case report was approved by the institutional ethics committee.


1997 ◽  
Vol 4 (1) ◽  
pp. 21-26 ◽  
Author(s):  
James F Lewis ◽  
Jasvinder S Dhillon ◽  
Ram N Singh ◽  
Craig C Johnson ◽  
Timothy C Frewen

Exogenous surfactant administration is currently being tested in patients with the acute respiratory distress syndrome (ARDS). The results of the studies have varied because several factors may influence the host’s response to this therapy. This clinical pilot study was designed to evaluate the safety and efficacy of exogenous surfactant administration in pediatric patients with ARDS. Surfactant was administered to 13 patients with severe lung dysfunction, and eight of these patients experienced a significant improvement in oxygenation after the first dose of surfactant. In these patients the exogenous surfactant was administered within 48 h of the diagnosis of ARDS, whereas in the five patients who did not respond, surfactant was administered several days after the onset of ARDS. Responders also spent fewer days on a mechanical ventilator and less time in intensive care compared with nonresponders. Based on the results of this pilot study, a more appropriate multicentre clinical trial should be designed to evaluate this treatment strategy.


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